Virtue® Male Incontinence Sling Study

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Virtue® Male Incontinence Sling

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, 4N 3M5
      • Sunybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Mortimer S Davis Jewish General Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N44
      • CHUS Hopital Fleurimont
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Orlando, Florida, United States, 32803
      • Winter Park Urology Associates
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Northeast Indiana Research
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Wayne State University
  • New York
    • New York, New York, United States, 10016
      • NYU Urology Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
  • Texas
    • Houston, Texas, United States, 77210
      • University of Texas-M.D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
• Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
• Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
• Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
• Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
• Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria:

• Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
• Subject has active urogenital infection or active skin infection in region of surgery
• Subject has serious bleeding disorders
• Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
• Subject has previous implant to treat SUI
• Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
• Subject has active urethral or bladder neck stricture disease requiring continued treatment
• Subject has urge predominant incontinence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Virtue® Male Sling; Subjects implanted with Virtue® Male Sling	Device: Virtue® Male Incontinence Sling; The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)	Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".	12 months post implant
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).	Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding "very much better" or "much better".	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Change in Subject Satisfaction Through ICIQ	The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.	Baseline
Assess Change in Subject Satisfaction Through ICIQ	The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.	12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.	12 months post implant
Assess Change in Pad Use	Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.	Baseline
Assess Change in Pad Use		12 months post-implant
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward		At implant
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies		At implant
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra		At implant

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Craig Comiter, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 11, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: stress urinary incontinence; urinary incontinence; Male sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CP001SU